Update: The following update relating to this announcement has been issued:

March 2, 2006 (NOT-OD-06-046) – Effective with the June 1, 2006 submission date, all R03, R21, R33 and R34 applications must be submitted through Grants.gov using the electronic SF424 (R&R) application. Replacement R03 (PAR-06-393) funding opportunity announcements have been issued for the submission date of June 1, 2006 and submission dates thereafter.

This initiative will provide funds for investigators at minority-serving institutions (MSIs) to advance research development capability for CAM-related research project grant applications in association with investigators at research-experienced institutions (REI). Applications will only be accepted from MSIs [e.g., Historically Black Colleges and Universities (HBCUs), Hispanic-Serving Institutions (HSIs), Tribal Colleges and Universities (TCUs), and Alaska Native or Native Hawaiian Serving Institutions] either in the United States or in territories under U.S. jurisdiction.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award also will vary. The total amount awarded and the number of awards will depend upon the number, quality, duration, and costs of the applications received.

This PAR will use the small grant (R03) mechanism.

Applications may be submitted by principal investigators from domestic, for-profit or non-profit organizations, public or private institutions such as universities, colleges, hospitals, and laboratories. Foreign institutions are not eligible.

Eligible principal investigators should have the skills, knowledge, and resources necessary to carry out the proposed research. Individuals from underrepresented racial and ethnic groups, as well as women and persons with disabilities, are encouraged to apply as PIs.

Applicants may submit more than one application, provided they are scientifically distinct.

NCCAM invites applications for small grants (R03) to assist investigators at Minority Serving Institutions (MSIs) in collaborating with investigators at research-experienced institutions (REI) to develop research capability and undertake focused collaborations in complementary and alternative medicine (CAM) research. The intent of this small grant program is to provide support for up to two years to encourage and foster research collaborations that will lead to the submission of competitive grant applications for collaborative CAM research. Applicants will be required to include, with the small grant application, letter(s) from one or more potential collaborating investigator(s) at research-experienced institutions with whom the subsequent R21 or R01 CAM-related research project grant will be submitted as a result of the collaboration, and identify potential project(s) to be undertaken with the collaborator(s).

Collaborative CAM Research Development Capability Enhancement (CCRDCE) grant applications submitted for this program announcement may lead to joint CAM research projects in any area of basic, clinical, behavioral, translational, or health services research. Each successful collaboration is expected to result in the subsequent submission from the MSI to NIH of a competitive investigator-initiated R21 or R01 research project grant application in association with the collaborating REI within one year of the end of the project period.

NCCAM seeks to encourage expansion of research capability in CAM at MSIs. To stimulate this effort, NCCAM proposes awarding small grants to investigators at MSIs in order to assist in developing productive research collaborations for CAM research between investigators at MSIs and at REIs. For the purposes of this Program Announcement, a minority serving institution (MSI) is defined as an Historically Black College or University (HBCU), Hispanic-Serving Institution (HSI), Tribal College or University, and Alaska Native or Native Hawaiian Serving Institution either in the United States or in the territories under U.S. jurisdiction. Research-experienced institutions are defined as those with a tradition of rigorous research and a record of successfully competing for biomedical research funding from NIH, as demonstrated by ranking in the top one hundred institutions receiving NIH funding. (See https://grants.nih.gov/grants/award/awardtr.htmfor current rankings.) MSIs wishing to collaborate with institutions that do not fall within the scope of this definition must contact NCCAM staff for approval prior to submitting an application.

BACKGROUND

Despite various initiatives by the National Institutes of Health (NIH), progress in realizing a significant increase in the number of underrepresented minority scientists who are successful in competing for NIH research grants has been slow. MSIs conduct high-quality programs for educating minorities and represent a rich source of talent with the appropriate cultural sensitivities and perspectives needed in biomedical research. However, many MSIs have had difficulties developing and sustaining independent programs in biomedical research, and there is a paucity of underrepresented minority scientists who are pursuing biomedical research careers. Although few MSIs are involved in complementary and alternative medicine (CAM) research, many of these institutions have the basic science and clinical research resources necessary for CAM research – resources that have resulted in productive research projects in other areas. Increasing the involvement of MSIs in CAM research will help diversify the CAM research community and can help to identify a potential role for CAM interventions in addressing health disparities. This initiative will target research capability enhancement for CAM research projects broadly, in order to create and sustain collaborations between investigators at MSIs and REIs in ways that take maximum advantage of their respective expertise and experience.

NCCAM defines CAM practices as those that are “…unproven by science and not presently considered an integral part of conventional medicine.” (http://nccam.nih.gov/about/plans/2005/index.htm) NCCAM groups the wide range of CAM modalities into four domains: 1) Mind-Body Medicine; 2) Biologically-based practices; 3) Manipulative and body-based practices; and 4) Energy Medicine. In addition, NCCAM studies whole medical systems, such as Ayurvedic medicine, traditional Chinese medicine, traditional Indigenous medicine, and homeopathy.

Mind-Body interventions use a variety of techniques designed to enhance the mind's capacity to affect body functions and symptoms. Mind-body techniques that are considered CAM include yoga, lifestyle behaviors such as tai chi, meditative strategies such as mindfulness meditation, and psychological strategies to manage stress. Also included are therapies that use creative outlets such as art, music or dance. Other techniques that were considered CAM in the past have become mainstream, such as patient support groups and cognitive-behavioral therapy.

Biologically-based practices for prevention and therapy use foods and their components, diets, and dietary supplements such as vitamins (in orthomolecular doses), herbs, and other natural products. Applicants planning to propose studies of biologically-based practices should consult NCCAM’s policy on biologically-active agents used in CAM (http://nccam.nih.gov/research/policies/bioactive.htm).

Manipulation and body-based methods in CAM are based on manipulation and/or movement of one or more parts of the body. Examples include chiropractic or osteopathic manipulation, and massage therapy.

Energy therapies are of two types: 1) Biofield therapies (e.g., Qi gong, Reiki, and Therapeutic Touch), which are intended to affect energy fields that surround and penetrate the human body, and 2) Bioelectromagnetic-based therapies that involve the unconventional use of electromagnetic fields such as pulsed fields, magnetic fields, or alternating current or direct current fields for selected purposes.

Some practices now considered to be CAM have long histories of use as traditional practices in populations and cultures outside the mainstream. America’s increasing cultural diversity and increasing minority populations necessitate a better understanding of their views on health, illness, and healthcare. Because of the integral role of traditional Indigenous/CAM practices in these cultures, a better understanding of these factors can provide insight into health behaviors and beliefs of the populations, potentially generating information that may inform the delivery of conventional health care and lead to reduced health disparities.

Statistics also document significant disparities for minority populations in health outcomes, such as quality of life, as well as processes, quality and appropriateness of care, the prevalence of certain conditions or diseases, and mortality. This program announcement invites applications to support the development of CAM research capability at MSIs by fostering collaborations that will lead to CAM research projects and encourages their focus on minority health and health disparities, including, but not limited to, the six health disparity conditions that the Department of Health and Human Services (DHHS) has targeted for elimination by 2010 – HIV/AIDS, cancer, cardiovascular disease, diabetes, adult and childhood immunization, and infant mortality.

SCIENTIFIC KNOWLEDGE TO BE GAINED

Many CAM therapies are in extensive use by the public, however, few have been thoroughly tested for safety and/or efficacy. In addition, the potential role of traditional or CAM practices in the elimination of health disparities remains to be defined. As part of its contribution to this effort, NCCAM seeks to fund research to determine the safety and efficacy of CAM interventions and their potential roles in contributing to the elimination of racial and ethnic health disparities. Research illuminating mechanisms of action for relevant CAM interventions as well as outcomes of CAM use for health disparities conditions or diseases also are of interest. By supporting the involvement of MSIs in CAM research, NCCAM seeks to generate new knowledge regarding CAM as it relates to the elimination of racial and ethnic health disparities.

Small grants may lead to a range of CAM research projects, including basic, pre-clinical, clinical, translational, and health services research. Because NCCAM previously announced the initiative, Secondary Analysis of Data on CAM Use in Minority Populations, applications leading to grants on epidemiologic studies of CAM use will not be considered responsive to this initiative.

establish productive research collaborations between investigators at MSIs and investigators at REIs; and

diversify the CAM research community.

Eligibility for funding through this Program Announcement is limited to minority-serving institutions (MSIs) as defined above. The intent is to attract new investigators and institutions to CAM research and also enable researchers at MSIs to establish productive collaborations that will help them compete successfully for peer-reviewed CAM research support. For grants that will lead to clinical studies of procedure-based CAM or traditional Indigenous medicine practices, the projects are required to include a knowledgeable practitioner as part of the proposed research team.

EXAMPLES OF RESEARCH TOPICS

Small grants funded through this program announcement may lead to a range of research projects. Applicants should consult the NCCAM website (http://nccam.nih.gov/research/priorities/index.htm#5) for relevant information regarding NCCAM’s current research priorities. NCCAM regularly examines and redefines its research priorities in order to fill gaps in its portfolio and capitalize on emerging opportunities to advance CAM research and to leverage the expertise and resources of other NIH Institutes and Centers (ICs) and agencies. The following list identifies the types of projects that may be undertaken within the context of NCCAM’s research priorities. This list is illustrative, is not exhaustive, is not intended to be exclusive, and is not in priority order. NCCAM has identified research areas of special interest as well as areas that are subject to a short “pause” in new research funding. Please see the NCCAM Web site (http://nccam.nih.gov/research/priorities/index.htm#5) for further information on NCCAM’s research priorities.

--- Mechanisms of action of complex botanicals in vitro, in animal models, and in human subjects treated with these botanicals.

--- Interactions between CAM and conventional therapeutic modalities.

--- Projects that study the effects of CAM interventions (including botanical substances or other natural products) alone or in combination with conventional therapy on the progression of disease or clinical outcomes.

--- Studies on potential roles for CAM interventions in patients to decrease symptoms, ameliorate medication side effects, or improve quality of life.

--- Small clinical studies to determine the safety, toxicity, pharmacokinetics, pharmacodynamics and the optimal dosage of an intervention as a prelude to a larger efficacy trial.

--- Qualitative research, such as detailed case studies and patient and health care provider interviews, ethnographic or ethnobotanical studies, to describe diagnostic and treatment approaches; to explore patient and health care provider preferences, beliefs and attitudes; and to investigate the relevance of those approaches to future clinical studies.

--- Studies of the effects of CAM interventions on patient adherence to conventional therapy.

--- Clinical studies of natural products, including functional foods, extracts, and their components, shown to have strong in vitro activity, especially relating to a health disparity condition.

--- Studies to address issues regarding the impact of insurance availability and costs of CAM on CAM use and the impact of managed care on CAM use.

--- Outcomes studies that include measurement of non-clinical patient-oriented variables as well as clinical variables in assessing results, such as measures of the patient's health-related quality of life, patient satisfaction, personal preferences, and functional abilities. For example, measuring the effect of CAM use on the results of treatment; determining whether CAM use affects patient satisfaction or makes a difference in the functional result of care, and whether CAM interventions can be linked causally to specific outcomes.

--- Studies that seek to clarify biomarkers of exposure to functional foods and their bioactive components, and determinants of biological response involved with minority health and health disparities.

This funding opportunity will use the R03award mechanism which permits direct cost funding of up to $50,000 per year for a project period of up to two years. The R03 grant is not renewable, and this specific program is not transferable to another institution.

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.This funding opportunity uses just-in-time concepts. It also uses the modular budget format described in the PHS 398 application instructions (see https://grants.nih.gov/grants/funding/modular/modular.htm). 2. Funds Available

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of NCCAM provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information

1.Eligible Applicants

1.A. Eligible Institutions

Applications will only be accepted from minority-serving institutions (MSI), defined for this program announcement as Historically Black Colleges and Universities (HBCUs), Hispanic-Serving Institutions (HSIs), Tribal Colleges, and Universities (TCUs), and Alaska Native or Native Hawaiian Serving Institutions either in the United States or in territories under U.S. jurisdiction. Alaska Native Serving Institutions are defined as institutions of higher education with undergraduate enrollment of at least 20% Alaska Native students. Native Hawaiian Serving Institutions are defined as institutions of higher education with undergraduate enrollment of at least 10% Native Hawaiian students.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

There are several Special Requirements and Provisions with which each MSI Collaborative CAM small grant application must comply:

1. There must be written "Letters-of-Commitment" from the MSI leadership and the collaborating REI leadership that are fully supportive of this activity and that commit the resources necessary to ensure that the collaborative partnership will have the maximum chance of success. A complete and specific description of such resources would include:

a. A specific statement detailing the percent effort of release/protected time (a minimum of 15 percent for the principal investigator at the MSI) as well as the activities from which each faculty member involved is being released (e.g., teaching, clinical, administrative duties). When the Principal Investigator from the MSI or the lead co-investigator at the REI is a less experienced investigator, there must be a written "Letter-of-Support" from a senior member (e.g., department chair, dean, or president) of the MSI or REI that identifies a mentor who will be responsible for career and professional development of the individual.

b. Provisions for space and facilities for new projects and other resources that will ensure the success of the collaborative partnership.

2. Each application must evidence a partnership between the MSI and the REI. The application should describe how the activities of the MSI and the REI both differ and complement each other in achieving the common objectives. Provide detailed descriptions of collaborative arrangements, including the nature of committees established to facilitate and monitor the collaborative research project (in both the initial research development and priority setting stages), frequency of meetings, workshops, types of activities, and communications, descriptions of intended communications processes, including a process for ongoing evaluation of the collaboration, general activities of the partnership, and how they may contribute effectively to achieving the collaboration’s goals and objectives.

3. Depending upon prior experience, interactions, and progress in developing the collaboration, the application must clearly describe a collaborative process that includes both of the following components:

a) Initial Research Development Stage in which the participants describe appropriate means of communicating and identifying areas of potential collaborations; and,

b) Priority-Setting Stage for selecting the areas of greatest promise for implementation as specific research project grants based on merit and potential to result in a successful grant application. The application also should describe the process used by the collaborating investigators to evaluate proposed projects.

4. If the application includes participation of Native American (American Indian/Alaska Native) or similar populations, a formal letter of support for the study from the Tribal Nation Leader or equivalent authority must be included.

The emphasis of this initiative is on establishing CAM research partnerships between MSIs and REIs, and developing CAM research capabilities at MSIs.

Applicants must delineate which personnel will be responsible for which aspects of research development and prioritizing activities, and describe expected responsibilities of the proposed personnel for this application and of prospective additional personnel in the subsequent application. Applicants must also detail specific timelines and milestones for meeting the objectives of the application, including goals for each activity (planning, training, infrastructure development, research, etc.) during each year of the award. Capacity-building activities may include training of investigators, technicians, practitioners and/or administrative personnel, informal meetings, workshops or small conferences, use of appropriate consultants, and analyses of extant data sets using new methodologies or approaches. Travel among sites for these purposes may be proposed. This PAR will not accept applications that are exclusively for meetings/travel and that do not have as their main goal the development of collaborations, planning for the resources needed to support them, and the development of the collaborative R21 or R01 research proposal. Applicants must outline the research project envisioned for the subsequent R21 or R01 project application and clearly explain how the two-year award will enhance the successful execution of the proposed research project.

Eligible applications may lead to joint CAM research projects in any area of basic, translational, clinical (including Phase I and Phase II, but NOT Phase III clinical trials), behavioral, or health services research. Applicants intending to propose research involving human subjects should refer to the NCCAM Terms of Award for Clinical Trials, available on the web at http://nccam.nih.gov/research/policies/terms-of-awards.htm. Applicants intending to propose research on botanicals or other complex natural products should refer to the Policy of NCCAM on Botanicals Research, posted on the NCCAM website at http://www.nccam.nih.gov/research/policies/naturalproducts.htm.

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

The small grant (R03) is used to provide research support specifically limited in time and amount for studies in categorical program areas. The small grant mechanism has the following features: There is a 10-page limit for Items a-d in the Research Plan. Although NCCAM does not expect applications submitted in response to this PA to have appendices, if submitted, the appendix may include only original, glossy photographs or color images of gels, micrographs, etc. provided that a photocopy (may be reduced in size) is also included within the page limits of the research plan. No publications or other printed material, with the exception of preprinted questionnaires or surveys, may be included in the appendix. For the purpose of this program announcement, the 10-page limit applies to the Development Capability Enhancement and Collaboration Plan (which replaces the Research Plan). Direct costs may not exceed $50,000 per year; the modular budget format therefore limits the budget to two modules. The project period is limited to two years. Two revisions are permitted. A grant award may not be renewed.

Prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed research

Name, address, and telephone number of the Principal Investigator

Names of other key personnel

Participating institutions

Number and title of this funding opportunity

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

In order to give potential applicants the opportunity to clarify any issues or questions concerning this PA, NCCAM expects to coordinate an Application Information Meeting (AIM) Conference Call. Potential applicants will have the opportunity to discuss application concepts and outlines of proposed applications with NIH staff. The conference call will be held on a date to be determined that may be found at the Additional Information URL, http://nccam.nih.gov/announcements/planning-grant.htm, scheduled to become active on November 18, 2005. Although a fee is not associated with this conference call, pre-registration is required. A summary of the presentations and issues discussed on the conference call will be made available through the NCCAM Web-site and on the Additional Information URL about two weeks after the conference call. Hard copies will be made available on request for those applicants without Web access.

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Applications must be received on or before the application receipt/submission date(s) described above (Section IV.3.A.). If an application is received after that date, it will not be reviewed.

Upon receipt applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at https://grants.nih.gov/grants/policy/policy.htm.

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

The small grant award will provide support to:

Further define the research to be proposed in the subsequent R21 or R01 application;

Solidify collaborative relationships and increase understanding between research partners;

Assess current resources and needs, and develop and initiate plans to address these needs so that the proposed subsequent research project can be successfully and appropriately conducted; and

o Identify appropriate training and other capacity-building activities (for the institutions and PIs).

Allowable costs include:

1. Administrative costs for managing the design and development of collaborative partnerships, such as salaries and travel for key personnel, equipment, and supplies to support an administrative structure; appropriate training costs for research or administrative personnel; and

2. Developmental costs for:

a. An initial research development stage: for workshops, seminars, retreats, and other forms of communication strategies to explore potential opportunities in CAM research; and,

b. A priority-setting stage, for selecting the areas of greatest promise for implementation as a research project for a subsequent R21 or R01 grant application.

6. Other Submission Requirements

Because the Table of Contents and Research Plan of the PHS 398 application are not specifically tailored to the unique objectives of the CCRDCE grant application, please follow the variations to the standard PHS 398 application as indicated below. Include the specified content.

1. Description, Performance Sites, and Key Personnel: Use Form Page 2 of the Form PHS 398 and list the Principal Investigator first and the Co-Investigators of the R03; then list all Key Personnel in alphabetical order. This section should include all professional individuals who serve in leadership roles. Include for each their degrees, department affiliation or equivalent, and research expertise/interests. Follow the instructions provided in the Form PHS 398.

2. Modular Budget for first and second Budget Periods -- identify in the budget justification activities for the Initial Research Development Stage and the Priority-Setting Stage. Provide specific justifications for costs for each year requested appropriate to the stage of development.

3. Budget justification for the collaborative arrangements.

4. Resources. Using Resources Format Page, follow the instructions in the Form PHS 398 application kit. For the MSI and the REI, include detailed information on the institutions’ research resources, expertise, and experience. Describe any synergies between the collaborating institutions that will contribute to the success of the proposed project.

5. The Development Capability Enhancement and Collaboration Plan (which replaces the Research Plan in PHS 398 application instructions). This section is limited to 10 pages. Revised applications may include an additional introduction of one page.

ii. Introduction to revised application, if applicable (not to exceed one page). Include a summary of the additions, deletions, and changes in the revised application, placing particular emphasis on responses to the criticisms and issues raised in the summary statement. Include a chronological description of activities that occurred since the original submission (meetings, research activities, etc.). The changes in the full text must be clearly marked by appropriate bracketing, indenting, or changes in the type setting, unless the changes are so extensive as to include most of the text.

iii. Background and Objectives. This section should describe the characteristics of the MSI and the collaborating REI that will contribute to the effort. It should clearly describe the nature of the interactions and deliberations that occurred between the MSI and collaborating institution and the individuals involved during the preparation of the application. Include a chronological table listing the specific first year and second year objectives that the collaboration expects to achieve. For each objective, include a brief statement about the separate contributions of the MSI and the REI in order to achieve success.

There should be a clear summary of the qualities of the REI that demonstrate that it has a highly organized research program that will complement the resources and experience of the MSI and will contribute to the success of the collaboration.

iv. Chronological Estimate of each Stage (Research Development, Priority-Setting). This section should include a chronological narrative or table listing the specific first and second year objectives that the collaborating investigators expect to achieve. For each objective, a brief statement should be made about the separate contributions of the MSI and the collaborating REI in order to achieve success. The final objective of the R03 must be the submission of a research project grant application (R21 or R01).

a. Research Development Stage: This section should clearly describe the kinds of activities that the MSI and collaborating REI will conduct to ensure a highly interactive and integrated effort between their faculties and scientists. The application should also relate each activity (e.g., workshop, retreat, executive meeting) to specific objectives above and name the specific investigators and faculty involved in each activity. The applicants should document any prior planning experience, interactions, and progress in this section.

b. Priority-Setting Stage: Clearly describe the process for prioritizing and selecting specific projects for implementation based on their merit and greatest potential for success.

6. Letters of Support from the MSI and the REI. There must be written Letters-of-Commitment from the MSI leadership and the collaborating institution’s leadership that are fully supportive of this activity and that commit the additional resources necessary to ensure that these partnerships will have the maximum chance of success. A complete and specific description of such resources would include the following:

a. A specific statement detailing the per cent effort of release/protected time of faculty (a minimum of 15 percent for the principal investigator at the MSI) as well as the activities from which each faculty involved is being released (e.g., teaching, clinical, administrative duties).

b. Provisions for space and facilities for projects and other resources that will ensure the success of the partnership. The commitments must come both from institutional leaders of the MSI (e.g., department chair, dean, or president) and the collaborating REI (e.g., department chair, dean, or president).

Because the annual direct costs for R03 applications submitted in response to this PA are limited to $50,000, all applications must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 at https://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398. Additional information on modular budgets is available at https://grants.nih.gov/grants/funding/modular/modular.htm.

Plan for Sharing Research DataNot applicable

Sharing Research ResourcesNot applicable

Section V. Application Review Information

1. CriteriaOnly the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications that are complete will be evaluated for scientific and technical merit by an appropriate review group convened by National Center for Complementary and Alternative Medicinein accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.

Receive a written critique

Receive a second level of review by the National Advisory Council on Complementary and Alternative Medicine.

The following will be considered in making funding decisions:

Scientific merit of the proposed project as determined by peer review

Availability of funds

Relevance of program priorities

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Reviewers also will consider the merit of the proposed project and its relation to the goals and priorities of the partnership.

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Reviewers also will consider the strength of the evidence that the researchers and faculty of the MSI and the REI worked closely together in the preparation of the application; .as applicable, the adequacy of provisions made for day-to-day oversight, coordination, support, and logistical services needed to make the collaboration successful; the adequacy of the methods proposed by the MSI and the REI to explore areas of research that will ensure highly interactive and integrated efforts between individual scientists and/or between faculty and scientists; the quality of the documented process used for identifying areas ready for prioritization; the adequacy and duration of the initial research development stage needed to identify areas of potential collaboration; and the adequacy of the proposed process for selecting projects for implementation based on their merit.

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? Reviewers also will consider the objectives, design, and direction of the project.

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? Reviewers also will consider the appropriateness and adequacy of the PI, faculty, and scientists identified from the MSI and the REI, as well as CAM practitioners (if included) to contribute effectively to each aspect of this effort; the adequacy of the experience and qualifications of the individuals from the MSI and REI who will take part in prioritizing and selecting specific projects for implementation; and the qualifications of the collaborating investigators to implement the small grant and the subsequent project.

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? Reviewers also will consider the degree to which the letters-of-support from senior faculty and/or institutional leaders evidence institutional commitments to ensure the success of the collaboration and (as indicated) address the need for mentoring of an inexperienced PI; the adequacy of the Career Development and Mentorship Plans if the PI and/or the collaborating investigator at the REI are junior investigators and the appropriateness of the mentors (if included); the degree to which the MSI is likely to improve its capacity and ability to address important issues in CAM research, develop independently supported research and capacity development programs and obtain financial support; as appropriate, the extent to which the local community will be involved in the planning process; the quality of the institutional environment (availability of institutional resources, accessibility of mentors, etc.); and the relationship of the project to other programs at the MSI and the REI and the likelihood that this activity will result in ongoing collaborative relationships between the partners.

2.A. Additional Review Criteria:

This initiative is broad in scope and focuses on the development of research capability. Reviewers will use considerable flexibility in determining the merit of applications. In addition to the above criteria, reviewers also will evaluate the potential of the application to develop a fundable project in the NIH peer review system.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

Required Federal Citations NIH Public Access Policy:NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

Standards for Privacy of Individually Identifiable Health Information:The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002 . The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at https://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.